Previous studies have shown that treatment with erythropoietin (Epo) improves anemia in approximately 20% of patients (pts) with myelodysplastic syndromes (MDS) whereas combination treatment with granulocyte colony-stimulating factor (G-CSF) may increase the response rate (RR). The aim of the present Greek multicenter study was to evaluate the RR and the response duration of the prolonged administration of Epo or Epo plus G-CSF in MDS pts. The eligibility criteria for entrance in the study were: primary MDS, Hb levels < 9g/dl and no clinically significant organ disease. 249 pts (169M/80F) with a median age of 74.5 years were included in this study: 94 RA, 61 RARS, 56 RAEB, 12 RAEB-t and 26 CMML. 194 pts were treated with Epo alone (Epo group) and 55 were treated with the combination of Epo plus G-CSF (combination group-CG). Epo was given on alternate days at a dose of 150U/kg, sc, for at least 6 months. G-CSF was administered daily, sc, at a dose of Sjig/kg. The erythroid response was defined as complete (CR) if an increase of Hb values above 2g/dl or a 100% decrease in transfusion requirements for at least 6 weeks were observed. An increase of Hb values of l-2g/dl and even a minimum decrease in transfusion requirements were considered as partial response (PR). In the Epo group the RR was 38.3% (28.5% CR and 9.8% PR) whereas in the CG it was 32.7% (27.2% CR and 5.5% PR). In the Epo group the RR for RA and RARS pts was 37.5% and 47.3% respectively while in the CG it was 31.8% and 26.3% respectively. In the Epo group response duration had a median time of 11 months and in the CG of 14 months. Kaplan-Meier analysis showed no differences between the two groups with respect to the time the response occurred. The median time for response was 6 months for both groups. The probability of response increases significantly with treatment duration in both groups. Time to treatment failure did not differ between the two groups. Multivariate analysis showed that MDS subtype was the most significant prognostic factor for response to treatment. These results suggest that prolonged administration of Epo or Epo and G-CSF might increase the RR in pts with MDS.
|Original language||English (US)|
|Issue number||11 PART I|
|State||Published - Dec 1 2000|
ASJC Scopus subject areas
- Cell Biology